A Randomized, Double-Blind Placebo-Controlled Exploration of a Topical Menadione-Containing Lotion to the Face for Prevention and Palliation of Epidermal Growth Factor Receptor Inhibitor-Induced Cutaneous Discomfort and Psychological Distress

Cutaneous discomfort as measured by the face pain scale question. Descriptive statistics and longitudinal plots will be used for summarizing cutaneous discomfort. [ Time Frame: Weekly during the 4-week treatment period ] [ Designated as safety issue: No ]

After completion of study treatment, patients are followed up for 4 weeks.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age 18 years or older.

Patient scheduled to start an epidermal growth factor receptor inhibitor (must be one of these three: panitumumab, erlotinib, cetuximab) within the next 3 days or patient has already started the epidermal growth factor receptor inhibitor but has not been on it for longer than 3 days and has no signs or symptoms potentially suggestive of EGFR inhibitor toxicity.

Ability to reliably apply Menadione Topical Lotion / placebo twice a day to the face.

Ability to complete questionnaire(s) by themselves or with assistance.

Any active facial and/or chest rash, including adult acne, at the time of randomization.

Cutaneous metastases, skin cancer, or a history of precancerous skin lesions involving the face and/or chest.

Use of topical corticosteroids on the face and/or chest at the time of study entry or their anticipated use in the next 8 weeks.

Any type of ongoing therapy for rash.

Any of the following:

Pregnant women

Nursing women

Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects

Use of any antibiotic at the time of study or their anticipated use in the 8 weeks immediately following study enrollment.

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393821